Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances

Author:

Orkin Aaron M.12,Gill Peter J.3,Ghersi Davina4,Campbell Lisa5,Sugarman Jeremy6,Emsley Richard7,Steg Philippe Gabriel8,Weijer Charles9,Simes John10,Rombey Tanja11,Williams Hywel C.1213,Wittes Janet14,Moher David15,Richards Dawn P.16,Kasamon Yvette17,Getz Kenneth18,Hopewell Sally19,Dickersin Kay20,Wu Taixiang21,Ayala Ana Patricia22,Schulz Kenneth F.2324,Calleja Sabine22,Boutron Isabelle25,Ross Joseph S.2627,Golub Robert M.2829,Khan Karim M.30,Mulrow Cindy31,Siegfried Nandi32,Heber Joerg33,Lee Naomi34,Kearney Pamela Reed35,Wanyenze Rhoda K.36,Hróbjartsson Asbjørn37,Williams Rebecca38,Bhandari Nita39,Jüni Peter40,Chan An-Wen41,Orkin Aaron M.42,Gill Peter J.42,Ghersi Davina42,Campbell Lisa42,Sugarman Jeremy42,Emsley Richard42,Steg Philippe Gabriel42,Weijer Charles42,Simes John42,Rombey Tanja42,Williams Hywel C.42,Wittes Janet42,Moher David42,Richards Dawn P.42,Kasamon Yvette42,Getz Kenneth42,Hopewell Sally42,Dickersin Kay42,Wu Taixiang42,Ayala Ana Patricia42,Schulz Kenneth F.42,Calleja Sabine42,Boutron Isabelle42,Ross Joseph S.42,Golub Robert M.42,Khan Karim M.42,Mulrow Cindy42,Siegfried Nandi42,Heber Joerg42,Lee Naomi42,Kearney Pamela Reed42,Wanyenze Rhoda K.42,Hróbjartsson Asbjørn42,Williams Rebecca42,Bhandari Nita42,Jüni Peter42,Chan An-Wen42,Kiermer Veronique42,Corrigan-Curay Jacqueline42,Concato John42,

Affiliation:

1. Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada

2. Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

3. Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada

4. National Health and Medical Research Council, Canberra, Australia

5. Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, London, England

6. Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland

7. Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, King’s College London, London, England

8. Université de Paris, AP-HP, Paris, France

9. Departments of Medicine, Epidemiology and Biostatistics, and Philosophy, Western University, London, Ontario, Canada

10. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia

11. Department of Health Care Management, Technische Universität Berlin, Berlin, Germany

12. University of Nottingham, Nottingham, England

13. National Institute for Health Research, Nottingham, England

14. WCG Statistics Collaborative, Washington, DC

15. Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada

16. Clinical Trials Ontario, Toronto, Ontario, Canada

17. Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

18. Tufts Center for the Study of Drug Development, Boston, Massachusetts

19. Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, England

20. Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

21. Chinese Clinical Trial Registry, Sichuan University, Chengdu, China

22. Gerstein Science Information Centre, University of Toronto, Toronto, Ontario, Canada

23. FHI 360, Durham, North Carolina

24. School of Medicine, University of North Carolina at Chapel Hill

25. Centre of Research in Epidemiology and Statistics, Université de Paris, Inserm, Paris, France

26. Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

27. The BMJ, London, England

28. Deputy Editor, JAMA

29. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois

30. Canadian Institutes of Health Research Institute of Musculoskeletal Health and Arthritis, Ottawa, Ontario, Canada

31. University of Texas Health Science Center, San Antonio

32. Alcohol, Tobacco, and Other Drugs Research Unit, South African Medical Research Council, Cape Town, South Africa

33. Lawrence Berkeley National Laboratory, Berkeley, California

34. The Lancet, London, England

35. Office of Extramural Research, Division of Human Subjects Research, National Institutes of Health, Bethesda, Maryland

36. Department of Disease Control and Environmental Health, School of Public Health, Makerere University, Kampala, Uganda

37. Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, University of Southern Denmark, Odense, Denmark

38. ClinicalTrials.gov, National Library of Medicine, National Institutes of Health, Bethesda, Maryland

39. Centre for Health Research and Development, Society for Applied Studies, New Delhi, India

40. Applied Health Research Centre, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

41. Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

42. for the CONSERVE Group

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference53 articles.

1. Measuring the incidence, causes, and repercussions of protocol amendments.;Getz;Ther Innov Regul Sci,2011

2. The scandal of poor medical research.;Altman;BMJ,1994

3. Biomedical research: increasing value, reducing waste.;Macleod;Lancet,2014

4. CONSORT 2010 statement.;Schulz;PLoS Med,2010

5. SPIRIT 2013 statement.;Chan;Ann Intern Med,2013

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3